| CTRI Number |
CTRI/2025/09/094390 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare The Effect Of Anu Tail Nasya And Pathyadishadanga Kwath In The Management Of Ardhavabhedaka W.S.R.To Migraine |
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Scientific Title of Study
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A Comparative Clinical Study To Evaluate The Effect Of Nasya Karma And Pathyadishadanga Kwath In The Management Of Ardhavabhedaka W.S.R. To Migraine |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukhdev Khatotra |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab |
| Address |
Opd Block Room No 1 Kayachikitsa Opd Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab
Mansa
PUNJAB
151505
India |
| Phone |
7889452996 |
| Fax |
|
| Email |
khatotrasukhdev2791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Gourisankar |
| Designation |
Professor and Head Department of Kayachikitsa |
| Affiliation |
Glocal University Delhi Yamunotri Marg State Highway 57 Mirzapur Pole Saharanpur Uttar Pradesh |
| Address |
Opd Block Room No 1 Kayachikitsa Opd Glocal College Of Ayurvedic Medical Sciences and Research Centre Glocal University Delhi Yamunotri Marg State Highway 57 Mirzapur Pole Saharanpur Uttar Pradesh
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9447308867 |
| Fax |
|
| Email |
drpgourisankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhdev Khatotra |
| Designation |
Associate Professor Department of Kayachikitsa |
| Affiliation |
Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab |
| Address |
Opd Block Room No 1 Kayachikitsa Opd Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab
Mansa
PUNJAB
151505
India |
| Phone |
7889452996 |
| Fax |
|
| Email |
khatotrasukhdev2791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab pincode 151505 |
|
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Primary Sponsor
|
| Name |
Dr Sukhdev Khatotra Associate Professor Department of Kayachikitsa |
| Address |
Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab pincode 151505 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sukhdev Khatotra |
Khalsa Ayurvedic Medical College and Hospital |
Room no 1 Khalsa Ayurvedic Medical College and Hospital Nangal Kalan Mansa Punjab 151505
Mansa
PUNJAB |
7889452996
khatotrasukhdev2791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Glocal University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyadishadang Kwatha, Reference: Sharangadhara Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: charaka samhita, Procedure details: Anu taila nasyam for 7 days.2.5 ml in each nostril)
| | 3 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: charaka samhita, Procedure details: anu taila nasya 2.5 ml in each nostril for 7 days)
(1) Medicine Name: pathyadishadang kwatha , Reference: sharangdhar samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Duration: 60 Days | | 4 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Patients with clinical features of Ardhavabhedaka (Migraine).
2.Patients with chronicity of disease for more than 6 months
3.Patients with an age group between 18-50 years and of either gender. |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of head injury, intracranial space-occupying lesions
(ICSOL)and brain infection.
2.Patients with uncontrolled metabolic disorders and hypertension. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Headache (paroxysmal unilateral headache)
2.Nausea
3.Vomiting
4.Aura
5. Associated Symptoms, like the stiffness of neck, heaviness of eyes, blurring of
vision, pratishaya, akshishotha , sleep disturbance, diarrhoea, photophobia, and phonophobia. |
baseline,30 day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| relief in symptoms |
baseline |
|
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Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Migraine is a Neuorvascular disorder, in most cases episodic, that usually lasts 4–72 hours, accompanied by nausea, vomiting and/or photophobia and phonophobia. It is sometimes preceded by a short lasting aura of unilateral, reversable visual, sensory or other symptoms. Migraine most often begins at puberty and generally affects those aged between 35 and 45 years. It is more common in women, possibly because of hormonal influences. Children typically experience migraine of shorter duration and abdominal symptoms are usually more prominent. The exact cause of migraine is currently unknown but it is thought to result from the release of pain producing inflammatory substances around the nerves and blood vessels of the head. It can be triggered by alcohol and certain foods ¹. KEY WORDS:-Ardhavabhedaka,Anutaila Nasya, Migraine Headache, kwatha. Pathayadishadang
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